NCT03411122

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.

Conditions

• Drug-drug Interactions

Interventions

Type	Name	Description
DRUG	napabucasin	Napabucasin will be administered at dose of 240 mg twice daily, every 12 hours (BID) on days 1-2 in period 1, and on days 1-11 in period 3.
DRUG	cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate	CYP450 probe drugs or BCRP transporter substrate will be administered once every period during days 1-4 in period 2, and days 6-9 in period 3.

Timeline

• Start date: 2017-06-30
• Primary completion: 2018-01-23
• Completion: 2018-01-23
• First posted: 2018-01-26
• Last updated: 2023-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study